a study of ramucirumab (ly3009806) in combination with capecitabine and cisplatin in participants with stomach cancer

Conditions: Metastatic Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary: the main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.


Eligibility criteria:
inclusion criteria: * have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (gej) adenocarcinoma. all histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible. * have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). participants whose disease has progressed after \>12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible. * have measurable or nonmeasurable but evaluable disease determined using guidelines in response evaluation criteria in solid tumors, version 1.1 (recist v 1.1). baseline tumor assessment should be performed using a high resolution computed tomography (ct) scan using iv and oral contrast unless clinically contra-indicated. magnetic resonance imaging (mri) is acceptable if a ct cannot be performed. * have a performance status of 0 or 1 on the eastern cooperative oncology group scale at baseline. * have adequate organ function. * have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-fu) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency). * have an estimated life expectancy of ≥12 weeks in the judgment of the investigator. exclusion criteria: * participants with adenocarcinoma of the esophagus are excluded. * participants with human epidermal growth factor receptor 2 (her2)-positive status. * participants receiving chronic therapy with nonsteroidal anti-inflammatory agents. * have radiation therapy within 14 days prior to randomization. * have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression. * have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization. * have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. * have symptomatic congestive heart failure (new york heart association ii-iv) or symptomatic or poorly controlled cardiac arrhythmia. * have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention. * have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter \[picc\] line) and the investigator does not anticipate any significant bleeding. * have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. * have a history of inflammatory bowel disease or crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization. * have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator. * the participant has: * cirrhosis at a level of child-pugh b (or worse) or * cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis. * have known allergy or hypersensitivity to any components of study treatment. * are pregnant or lactating.